Oestrogel: new packaging (yet again)? - Thread 2

[ConfusedEasily]

Carrying on from a previous thread by Cosmetichamster which can be found here:

https://www.mumsnet.com/talk/menopause/4696464-oestrogel-new-packaging-yet-again

@Namddf I'm on Estrodot 100mcg patches

I'm on Estradot 75. I was on three pumps of gel when it all unravelled, going up to four with absolutely no affect.
Estradot patches are so tiny, and seem to work well, once I worked out where best to stick 'em!

@Namddf I was on Evorel 100 patches but felt so bloated so weaned myself down to 75mcg and then switched to the gel to see if this helped, which it did a little bit. I am hoping to go down to 50mcg when my levels have settled a bit. Evorel definitely makes me bloat and my chest gets bigger.

My mood is stable on 75mcg and I can sleep so I will have to put up with the negative weight issue.

As an aside I have been using mounjaro weight loss injections for four months with in 24hrs my joint pain was massively reduced and with in a few days I realised my brain fog had too. I’ve been on HRT for 7yrs and was fine until they messed with the gel. Yes I’ve lost weight now but this drug is also having some hormonal impact which has been fab. So if you need to lose weight as well it’s definitely worth a try if you can afford it privately.

Haven’t been on here for a while. I’d resigned myself to feeling pretty rubbish on the cylindrical bottle and a patch(I’m in surgical menopause).
And I’d given up sadly. Then by chance my last prescription I got the old style bottles of oestrogel. My god, I’d forgotten how I could feel- back to myself- sharpness & sense of humour returned, able to regulate emotions properly not to mention physically feeling really well. This next prescription is back to cylinders again. I was thinking maybe it’ll be ok. No. Within days I’m feeling crabby, depressed & the brain fog has returned. I’m weighing my dose again and it’s measuring at 120 but can be 109 some days. 😞

Has anyone else seen a few old style bottles around? And are Besins changing back to the old style bottle any time?

This is my first time posting here and I see that a lot of other people are also having issues with symptoms returning with the cylindrical bottles of Oestrogel. I was wondering if anyone had a package leaflet from the old bottle (that we all seem to like!) and see what it says under the manufacturer? The leaflet in the new style bottle has two and it states the gel is made by one or the other. It would be interesting if that is the same on the previous versions.

I found a similar situation with Evorel at one point. They worked fine for me and then suddenly stopped working, when I looked into it they were no longer being made by Jansen but a different company that made generic patches who effectively bought the name. I couldn't absorb the estradiol from the new patch. I wonder do we have a similar issue here?

Yes, that's what I have concluded after much research and investigation into this issue. You can read the first thread /very long) here https://www.mumsnet.com/talk/menopause/4696464-oestrogel-new-packaging-yet-again

Same formula, different manufacturers (Delpharm in Belgium, and Besins, in Belgium or in France), different raw material suppliers (hard to pinpoint, but it's highly probable that they are different), two different pump suppliers (Nemera and Lablabo).

I have just checked the MHRA website for the latest Oestrogel patient information leaflets (yes, there are 3 for the 'same product'), which you can view here https://mhraproducts4853.blob.core.windows.net/docs/adba3ee8c5fb48816a1fd3af01dcd8f5e7e430c5

If the links don't work (you have to accept the disclaimer before the page opens), just type Oestrogel on the MHRA products page https://products.mhra.gov.uk/ , tick the 'I have read and understand the disclaimer' box, click 'agree', and click PIL of this product OESTROGEL PUMP-PACK 750 MICROGRAMS/ACTUATION GEL
leaflet MAH BRAND_PL 28397-0002.pdf The other PIL are for the parallel imports (PLPI).

You will have access to 3 PILs. Basically, they have different instructions for different pumps, but remember that both cylindrical bottles have the same pump/bottles, the only difference disclosed by Besins is that one has an adhesive label and the other a printed label.The other pump (conical bottlle) doesn't have the 'stopper', hence the need for a separate leaflet.

This change has been last updated on the EMC (electronic medicines compendium) on 12 July 2024 (attached snapshot). 'Joint PIL superseded by individual PILs).

Based on this evidence, I think Besins will keep manufacturing the gel at both facilities (Dogenbros, Belgium, and Montrouge, France) for a long time, and unfortunately Besins is not required by law to disclose which batches are manufactured in Belgium and which are manufactured in France. IMHO, this is a disgrace.

Just to confirm your suspicion regarding Evorel. When Theramex bought Evorel from Janssen, they have contracted two different manufacturers, so it's the same situation.

From Evorel PIL:

What Evorel looks like and contents of the pack
Evorel comes in a memory pack containing eight patches.
Evorel 50 also comes in packs of two and twenty four patches.
Evorel 25 is marked CE25 and has a surface area of 8 sq cm
Evorel 50 is marked CE50 and has a surface area of 16 sq cm
Evorel 75 is marked CE75 and has a surface area of 24 sq cm
Evorel 100 is marked CE100 and has a surface area of 32 sq cm
The patches are square with rounded corners. They are clear with a sticky backing that can be stuck to the skin. Each patch comes in a protective sealed pouch.

Marketing Authorisation Holder

Theramex HQ UK Limited
5th Floor
50 Broadway
London
SW1H 0BL
United Kingdom

Manufacturer

Aesica Pharmaceuticals GmbH
Alfred-Nobel-Str. 10
40789 Monheim am Rhein
Germany

LTS Lohmann Therapie-Systeme AG
Lohmannstr.2
56626 Andernach
Germany

I have discovered a solution for me. I have bought some very sensitive scales and I put my oestrogel dose on the scales. It is very obvious that some of the cylindrical bottles do not dispense a consistent dose, especially at the end and beginning of using the dispenser.

I have arbitrarily chosen a 2.8g dose and I make sure that appears on the scales, removing or adding gel as required. I then apply it to me from the scale plate.

Since doing that I have had no more problems with any batch of oestrogel.

The other thing that has helped my postmenopausal state more than anything else, is that for the past 3 months I have started taking 1mg of melatonin one hour before I want to sleep.

It is miraculous. My chronic insomnia of the past 3 years is gone. I get 6 to 8 hours of quality sleep. I may wake up several times but I now go straight back to sleep and many nights are unbroken. I think I was suffering from melatoninpause as well as menopause ! Supplementation has given me back my health.

Correction - 2.8mg dose !

Correction - 2.8g. I was right the first time. I wish I could edit .

@Azaleah re your posts about different manufacturer plants. I have a suspicion that the defective bottles are sold to the UK since we upped our need + left the EU.
I dont think this a malicious intent per se but I wonder if the conical bottle is only being distributed in other countries in Europe (France,Spain etc). Doesn’t help really. I think my obtaining 3 conical bottles was a complete fluke and Besins won’t be changing a thing. As you say why would they if they don’t have to or are not being held to account? I think Pharmaceutical giants like these operate by their own rule book which unfortunately is not questioned. They are far too powerful for anyone to challenge it. Shame on them.

@Lotusflower75 When I was investigating this issue I found that the cylindrical bottle was sold in some European countries like Germany (brand name Gynokadin), alongside the conical bottles, but it seems the conical bottle is the current version over there. Hard to know for sure though because some countries don't advertise them on the internet. It would be interesting to know from women living in Europe which versions are available now. The UK is Besins' biggest market, so your suspicion is probably correct.

I thought this might be of interest to Oestrogel users. This is a Google translation of the most recent Oestrodose leaflet. The bold text is interesting because it is different from the Oestrogel leaflet.

"Mode and route of administration

Transdermal route.

The application will be made to a large area of clean skin (arms, upper part of the buttocks, lower part of the abdomen, lumbar region, upper part of the thighs).

The gel should not be applied to the breasts or mucous membranes.

Massage is unnecessary but it is advisable to let it dry for 2 minutes before putting on clothing. The gel does not stain.

It is advisable to wash your hands after applying the gel.

Do not let other people touch the area of skin where the gel was applied until the gel has dried and cover yourself with clothing if necessary."

The original leaflet can be read here https://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php?specid=63071975&typedoc=N

I've read a lot of comments (including a podcast with Dr. Heather Currie of MenopauseMatters) stating that the top of the bum is the best absorption site for estradiol patches, so perhaps it's the same with the gel, at least for some women?

where do you get the melatonin from please?

@SaltySeaCat I have ordered melatonin from the US without any problems

Thought this article might be useful for those finding sleep tricky.

https://sleepdoctor.com/melatonin/foods-with-melatonin/

Can I ask how? Amazon.com won’t ship melatonin to the UK.

I get mine from Biovea

I’ve just noticed this thread. I’ve been on oestrogel for just over a year and without knowing about this information, I’d wondered if there was a change in the gel.
in the evening when I have a shower, my legs go all gooey as if the gel is still there (even though it’s dried in from the morning).
I’ve not had the hot sweats I had before but I’ve had alot of emotional symptoms , poor sleep, anxiety.
I was meant to get my levels checked (privately) a few months ago but very got round to it. Might do that now.

it’s really upsetting to hear the experiences everyone has had, having previously had good symptom control.

@Namddf I have ordered it from Pipingrock.com and it is posted internationally. Although looking back at my emails, I haven't ordered any for a while but I'm not aware of anything having changed.

Sorry to hear you’ve had problems too with oestrogel. I’ve now switched to Sandrena (plus a 50 Evorel patch twice a week). It’s not as good as the conical bottle but it’s better than it was on the cylindrical bottle.